
Phamatech
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QUICKSCREEN PRO DRUG CUP, MODEL 9195X is an FDA 510(k)-cleared medical device (K001397) manufactured by Phamatech. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2000. Regulation: 8.